Senior Clinical Research Manager

2 - 6 years

0 Lacs

Posted:3 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

The Manager of Clinical Research will lead and manage clinical trials and research studies to ensure timely completion within budget and compliance with regulatory standards. Supervising research teams, collaborating with cross-functional departments, and providing strategic direction for clinical research activities are key responsibilities. You will be responsible for planning, initiating, and managing clinical research projects from start to finish. Coordinating and overseeing the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets is essential. Compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards must be ensured. Oversight on recruitment, enrollment, and monitoring of clinical trial subjects is part of the role. Managing relationships with clinical research organizations (CROs), investigators, and external vendors is key. Leading and mentoring clinical research staff, ensuring effective performance, assigning tasks based on project needs, and providing ongoing professional development are critical leadership responsibilities. Additionally, overseeing regulatory documentation, monitoring compliance with regulations and company policies, and ensuring timely reporting of adverse events are important aspects of the role. Collaboration with scientific and medical teams to develop clinical trial protocols, ensuring adherence to study objectives, regulatory standards, and ethical guidelines, and evaluating feasibility and risk of proposed studies are part of the responsibilities. Data management, reporting, preparing progress reports, budget management, resource allocation, fostering communication between teams, partners, and stakeholders, resolving issues related to study execution, identifying areas for process improvement, and implementing best practices are key components of this role. Qualifications for this position include a Bachelor's degree in Life Sciences, Clinical Research, or related field (Master's or higher preferred), 2-3 years of experience in clinical research, in-depth knowledge of clinical trial management, regulatory requirements, and GCP. Skills required include project management, leadership, organizational skills, communication, interpersonal skills, proficiency in clinical research software, problem-solving, and decision-making abilities. Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred. This full-time position may be in-office or remote, with occasional travel required to clinical trial sites and partner organizations.,

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